WVSM Pro (Series) (500-0030-XX)

WVSM Pro (Series) (500-0030-XX) is an FDA 510(k)-cleared medical device (K233354) manufactured by Athena Gtx, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 2024. Regulation: 8.